Vial

MARCH 1, 2024

billion in 2023 attributable to its laboratory products and biopharma services segment (53.8% By type of service, clinical research services accounted for the lion’s share of the North American CRO services market, followed by early-phase development services, laboratory services, and consulting services.

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NIH Director's Blog: Drug Development

SEPTEMBER 29, 2015

As an important step in this direction, NIH-funded researchers at the Morgridge Institute for Research and University of Wisconsin-Madison have produced neural tissue chips with many features of a developing human brain. References : [1] Clinical development success rates for investigational drugs. Nat Biotechnol.

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Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 2018;10(4):539–46. Harth S, Frisch C. 2021;291–306.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

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The Premier Consulting Blog

JULY 9, 2023

(Degradants are impurities arising from the degradation of the drug substance or a reaction with an excipient and/or the immediate container.) Impurities or degradants that exceed qualification thresholds and have not been adequately tested in Good Laboratory Practices (GLPs) toxicology studies are often encountered during development.

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PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. This comes as the demand for qualified clinical research associates (CRAs) is expected to increase by more than 36% in the next decade.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. Understanding the Numbers: How Many Clinical Trials Utilize CROs?

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The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). OSLO, Norway , Oct. Fennel cover the key scientific focus areas of Targovax.

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The Pharma Data

MAY 31, 2022

The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Additional regulatory filings outside of the US are also planned in 2022.

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The Pharma Data

JUNE 26, 2021

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Current clinical development programs include Libtayo in combination with chemotherapy for advanced NSCLC irrespective of PD-L1 expression and Libtayo monotherapy for advanced cervical cancer.

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Agency IQ

JUNE 26, 2023

While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs. Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g.,

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The Pharma Data

JUNE 26, 2021

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Current clinical development programs include Libtayo in combination with chemotherapy for advanced NSCLC irrespective of PD-L1 expression and Libtayo monotherapy for advanced cervical cancer.

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The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

OCTOBER 28, 2020

Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 Senior Vice President and Head of Global Clinical Development at Regeneron.

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The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. All patients entering the trial were hospitalized with laboratory-confirmed COVID-19 requiring low-flow oxygen, and all received other background standard-of-care as required.

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The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

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Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. The first (pages 1-5) explains what regenerative medicine products are, provides an overview of what “risk management” means, and cites the requirements that drug developers must satisfy per the U.S.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development.

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The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). Non-GAAP net income per share – diluted (1). $. Business Highlights.

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Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

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PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

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Agency IQ

AUGUST 2, 2024

The FDA has a seat on ONC’s Health Information Technology Advisory Committee (HITAC), which advises ONC on EHR and laboratory data standards, as well as issues in data continuity and quality. That entity is the driving force behind the idea of AI “Assurance Labs,” third-party laboratories that pressure-test AI methodologies.

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Precision for Medicine

JANUARY 23, 2023

SolveBio’s intelligent technologies and enterprise data management platform has integrated into QuartzBio’s suite of SaaS solutions, providing a single, scalable solution supporting clinical sample inventory management and biomarker data management for the biotech and pharmaceutical sectors. Canada, Europe and Australia.

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. on October 22, including those at high risk of severe complications of COVID-19 disease.

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The Pharma Data

DECEMBER 27, 2020

Grade 3 or 4 cytopenias, including neutropenia (27%), thrombocytopenia (10%), and anemia (8%) based on laboratory measurements, were reported in patients treated with BRUKINSA monotherapy. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias.

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The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. Christophe Le Tourneau, M.D.,

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FDA Law Blog: Drug Discovery

JULY 9, 2024

For drugs, the rationale should describe data and information, if any, that suggest the potential for differential safety and effectiveness across the clinically relevant population, such as possible differences in PK or PD. providing language assistance); Reducing participant burden (e.g.,

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The Pharma Data

OCTOBER 26, 2020

The increase was primarily driven by higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower laboratory, travel and meeting expenses due to the COVID-19 pandemic. Non-GAAP R&D expenses were $2.3

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Agency IQ

AUGUST 16, 2024

The final version newly clarifies that oncolytic viruses also fall outside the scope of the document and includes a new disclaimer that the guidance is not intended to address unique considerations of pediatric drug development. To be [administered with] food or not to be?

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Agency IQ

JUNE 28, 2024

The new DAP guidance goes into more detail about research programs with “several clinical studies” that are subject to DAP requirements. The draft guidance offers some information for how to think about DAPs under “multi-regional clinical studies,” including “globally conducted clinical development programs.”

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